1. Ambulatory continuous peripheral nerve blocks to treat postamputation phantom limb pain: a multicenter, randomized, quadruple-masked, placebo-controlled clinical trial
- Author
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Sarah J. Madison, Daniel I. Sessler, PAINfRE Investigators, Jennifer Padwal, Steven P. Cohen, Michael L. Kent, Wael Ali Sakr Esa, Steven R. Hanling, Kamal Maheshwari, Brian M. Ilfeld, James C. Eisenach, Chao Ma, Edward J. Mascha, Alparslan Turan, Edward R. Mariano, and Bahareh Khatibi
- Subjects
medicine.drug_class ,medicine.medical_treatment ,Continuous peripheral nerve blocks ,Chronic pain ,Perineural local anesthetic infusion ,Placebo ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,030202 anesthesiology ,Interquartile range ,law ,medicine ,Humans ,Ropivacaine ,Peripheral Nerves ,Anesthetics, Local ,Pain, Postoperative ,business.industry ,Local anesthetic ,Nerve Block ,medicine.disease ,body regions ,Anesthesiology and Pain Medicine ,Phantom Limb ,Neurology ,Amputation ,Anesthesia ,Nerve block ,Neurology (clinical) ,business ,Phantom pain ,Ambulatory analgesia ,030217 neurology & neurosurgery ,Research Paper ,medicine.drug - Abstract
Supplemental Digital Content is Available in the Text. A 6-day ambulatory continuous peripheral nerve block reduces phantom limb pain and pain-induced physical and emotional dysfunction for at least 4 weeks after treatment., Phantom limb pain is thought to be sustained by reentrant neural pathways, which provoke dysfunctional reorganization in the somatosensory cortex. We hypothesized that disrupting reentrant pathways with a 6-day-long continuous peripheral nerve block reduces phantom pain 4 weeks after treatment. We enrolled patients who had an upper- or lower-limb amputation and established phantom pain. Each was randomized to receive a 6-day perineural infusion of either ropivacaine or normal saline. The primary outcome was the average phantom pain severity as measured with a Numeric Rating Scale (0-10) at 4 weeks, after which an optional crossover treatment was offered within the following 0 to 12 weeks. Pretreatment pain scores were similar in both groups, with a median (interquartile range) of 5.0 (4.0, 7.0) for each. After 4 weeks, average phantom limb pain intensity was a mean (SD) of 3.0 (2.9) in patients given local anesthetic vs 4.5 (2.6) in those given placebo (difference [95% confidence interval] 1.3 [0.4, 2.2], P = 0.003). Patients given local anesthetic had improved global impression of change and less pain-induced physical and emotional dysfunction, but did not differ on depression scores. For subjects who received only the first infusion (no self-selected crossover), the median decrease in phantom limb pain at 6 months for treated subjects was 3.0 (0, 5.0) vs 1.5 (0, 5.0) for the placebo group; there seemed to be little residual benefit at 12 months. We conclude that a 6-day continuous peripheral nerve block reduces phantom limb pain as well as physical and emotional dysfunction for at least 1 month.
- Published
- 2020